The FDA on Tuesday approved the first over-the-counter COVID-19 test involving a nasal swab — and near-instant results.
“By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,’’ said Stephen Hahn, commissioner of the Food and Drug Administration, in a statement on the agency’s Web site.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” Hahn said.
The agency has already approved more than 25 consumer at-home coronavirus tests — but until now, the collected samples had to be sent away to a lab for results.
The diagnostics company Ellume makes the new completely at-home test.
There are drawbacks to it, but its development is still a major step in diagnosing the virus, said Jeff Shuren, the FDA’s director of its Center for Devices and Radiological Health.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” Shuren said in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”